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New combo shot shows promise for kidney health in diabetes patients

NCT ID NCT06131372

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new medicine called CagriSema (a combination of two drugs) can reduce kidney damage in people with chronic kidney disease, type 2 diabetes, and overweight or obesity. About 626 participants received either CagriSema, one of the two drugs alone, or a placebo for around 35 weeks. The main goal was to see if CagriSema lowers a key marker of kidney damage (UACR) better than the other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

626 people

The number who actually took part.

Started

Apr 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female. * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening. * HbA1c less than or equal to (≤) 10.5% (91 millimoles per mole \[mmol/mol\]) as assessed by central laboratory at screening. * Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and \< 90 milliliters per minutes per 1.73\^m\^2 (mL/min/1.73 m\^2) (CKD-EPI 2021) as assessed by central laboratory at screening. * Albuminuria defined by UACR ≥ 100 and \< 5000 milligram per gram (mg/g) as assessed by central laboratory at screening. * Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations. * Use of any glucagon-like peptide-1 receptor agonist (GLP-1RA) (including medication with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to screening. * Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening. * Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) within 5 years before screening.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease Obesity Type 2 diabetes

Contacts and locations

Locations

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, 54642, Greece

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, GR-54642, Greece

  • "Laiko" General Hospital of Athens

    Athens, 11527, Greece

  • "Laiko" General Hospital of Athens

    Athens, GR-11527, Greece

  • Advent Health Translational Research Institute

    Orlando, Florida, 32804, United States

  • Albany Medical College

    Albany, New York, 12203, United States

  • Belinus Bt.

    Debrecen, Hajdú-Bihar, 4025, Hungary

  • Bluewater Clin Res Group Inc

    Sarnia, Ontario, N7T 4X3, Canada

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103, United States

  • Békés Megyei Központi Kórház

    Gyula, 5700, Hungary

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Carteret Medical Group

    Morehead City, North Carolina, 28557, United States

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

    Saint-Herblain, 44800, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000, France

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

    Toulouse, 31059, France

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2, Canada

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200, France

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6, Canada

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4, Canada

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1, Canada

  • Centricity Research Vaughn Endocrinology

    Concord, Ontario, L4K 4M2, Canada

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC, Argentina

  • Centro Médico Privado San Vicente Diabetes

    Córdoba, X5006IKK, Argentina

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600GNY, Argentina

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Chu de Reims-Hopital Maison Blanche

    Reims, 51092, France

  • Clinical Advancement Center

    San Antonio, Texas, 78212, United States

  • Clinical Investigation Specialists Inc, Kenosha

    Kenosha, Wisconsin, 53144, United States

  • Ctr de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5, Canada

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 91355, United States

  • Eastern Nephrology Associates, PLLC

    New Bern, North Carolina, 28562, United States

  • Elite Research Center

    Flint, Michigan, 48532, United States

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001, India

  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.

    Olsztyn, 10-117, Poland

  • Fukuwa Clinic

    Tokyo, 104-0031, Japan

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031, Japan

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300, Argentina

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132, Poland

  • Gaja Poradnie Lekarskie

    Poznan, 61-251, Poland

  • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter

    Athens, 11527, Greece

  • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter

    Athens, GR-11527, Greece

  • General Hospital of Lamia

    Lamia, 35100, Greece

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, 57010, Greece

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, GR-57010, Greece

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54642, Greece

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635, Greece

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, GR-54635, Greece

  • General University Hospital of Patras,Nephrology clinic

    Pátrai, GR-26504, Greece

  • General University Hospital of Patras,Nephrology clinic

    Rio, Patra, 26504, Greece

  • General hospital of Athens 'G.Gennimatas'

    Athens, 11527, Greece

  • General hospital of Athens 'G.Gennimatas'

    Athens, GR-11527, Greece

  • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu

    Le Creusot, 71200, France

  • HUMAN-CARE, s.r.o.

    Košice, 040 01, Slovakia

  • Hamilton Medical Rsrch Grp

    Hamilton, Ontario, L8L 5G4, Canada

  • Heritage Valley Multispeciality Group Inc

    Beaver, Pennsylvania, 15009, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Fundación Alcorcón

    Alcorcón, 28922, Spain

  • Hospital Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

    São Paulo, 04038-002, Brazil

  • Hôpitaux Saint-Joseph & Marie-Lannelongue

    Paris, 75674, France

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562, Greece

  • Instituto Pró-Renal Brasil

    Curitiba, Paraná, 80440-020, Brazil

  • John Muir Physicians Network

    Concord, California, 94520, United States

  • KARDIO-SANUS, spol. s r.o.

    Bratislava, 84108, Slovakia

  • Kanno Naika_Internal Medicine

    Mitaka-shi, Tokyo, 181-0013, Japan

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • King Edward Memorial Hospital

    Pune- Maharashtra, Maharashtra, 411011, India

  • Kresmed Sp. z o. o.

    Bialystok, Podlaskie Voivodeship, 15-481, Poland

  • Lausmed Kft.

    Baja, Bács-Kiskun county, 6500, Hungary

  • Life Spring Research Foundation LLC

    Miami, Florida, 33130, United States

  • Lifecare Hospital and Research Centre

    Bengaluru, Karnataka, 560066, India

  • M2M Med. Badania Sp. z o.o.

    Chorzów, Silesian Voivodeship, 41-500, Poland

  • M2M Med. Sp. z o.o. Sp. j.

    Chorzów, 41-500, Poland

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01, Slovakia

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086, India

  • Maharaj Nakorn Chiang Mai Hospital_Nephrology

    Chiang Mai, Mueang Chiang Mai, 50200, Thailand

  • Main Street Physician's Care

    Little River, South Carolina, 29566, United States

  • Maulana Azad Medical College

    Delhi, New Delhi, 110002, India

  • Mautalen Salud e investigación

    CABA, Buenos Aires, C1128 AAF, Argentina

  • Minami Akatsuka Clinic

    Mito-shi, Ibaraki, 311-4153, Japan

  • NIZAM'S Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500082, India

  • NYU Langone Nephrology Associates

    Mineola, New York, 11501, United States

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435, Poland

  • New York University Grossman School of Medicine

    New York, New York, 10016, United States

  • Nippon Kokan Fukuyama Hospital_Diabetology

    Fukuyama-shi, Hiroshima, 721-0927, Japan

  • Nishiyamado Keiwa Hospital_Internal Medicine

    Ibaraki, 331-0133, Japan

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583, United States

  • North America Research Institute

    San Dimas, California, 91773, United States

  • Northeast Research Institute

    Fleming Island, Florida, 32003, United States

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Ohio- Advanced Medical Research

    Maumee, Ohio, 43537, United States

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik

    Bialystok, Podlaskie Voivodeship, 15-351, Poland

  • Osvaldo A. Brusco MD

    Corpus Christi, Texas, 78414, United States

  • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum

    Pécs, Baranya Vármegye, 7623, Hungary

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507, Poland

  • Phramongkutklao Hospital

    Bangkok, 10400, Thailand

  • Pratia S.A.

    Gdynia, 81-338, Poland

  • Pratia S.A.

    Katowice, 40-081, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800, Poland

  • Sasaki Internal Medicine

    Hokkaido, 062-0007, Japan

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012, India

  • Shri Mahant Indiresh Hospital

    Dehradun, Uttarakhand, 248001, India

  • Siriraj Hospital

    Bangkok Noi, Bangkok, 10700, Thailand

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Siófoki Kórház, Diabetológiai Szakrendelés

    Siófok, Somogy County, 8600, Hungary

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224, United States

  • Southwest Houston Research Ltd

    Houston, Texas, 77099, United States

  • Sunrise Hospital

    Vijayawada, Andhra Pradesh, 520002, India

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032, Hungary

  • Tatratrial s.r.o.

    Rožňava, 048 01, Slovakia

  • Thammasat Hospital_CRC

    Pathum Thani, 12120, Thailand

  • Thammasat University Hospital

    Klong Luang, Changwat Pathum Thani, 12120, Thailand

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027, Japan

  • UHN-Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

  • Univ Gen Hospital Larisa

    Larissa, 41110, Greece

  • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease

    Larissa, GR-41110, Greece

  • Univ. of Nebraska Medical Center_Omaha

    Omaha, Nebraska, 68198, United States

  • University General Hospital Of Heraklion

    Heraklion, Crete, 71500, Greece

  • Univerzitna nemocnica L. Pasteura Kosice

    Košice, 040 01, Slovakia

  • Valley Research

    Fresno, California, 93720, United States

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383, United States

  • Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.

    Košice, 040 01, Slovakia

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